Psa Series
FDA 510(k) K123916 · Osypka Medical, Inc.
510(k) numberK123916
Submission
- Device name
- Psa Series
- Applicant
- Osypka Medical, Inc.
La Jolla, CA, US - Received
- December 19, 2012
- Decision date
- April 9, 2013
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTE – Pulse-Generator, Pacemaker, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3600
- Specialty
- Cardiovascular
Other 510(k)s with product code DTE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241781 | Solo Pace ControlDTE · Traditional | Solo Pace, Inc. | 01/10/2025SE |
| K232721 | Lifetech Cardio Temporary PacemakerDTE · Special | Shenzhen Lifetech Cardio Medical Electronics… | 01/07/2024SE |
| K201011 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 05/13/2020SE |
| K190825 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 04/30/2019SE |
| K182839 | Lifetech Cardio Model 8301 Temporary PacemakerDTE · Traditional | Shenzhen Lifetech Cardio Medical Electronics… | 02/28/2019SE |
| K181973 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 08/21/2018SE |
| K180873 | Medtronic Model 53401 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 04/19/2018SE |
| K162054 | Medtronic Temporary External Pacemaker 53401DTE · Traditional | Medtronic, Inc. | 10/18/2016SE |
| K162550 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 10/12/2016SE |
| K150246 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 02/18/2015SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K082242 | Icon, Model C3DSB · Special | 10/08/2008SE |
| K081035 | Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon…DSB · Special | 05/30/2008SE |
| K070985 | Aesculon CHF, Hypertension & Pacemaker ClinicDSB · Traditional | 02/01/2008SE |
| K033130 | Pace 101/PACE 101H, Model 3077 Ssi Temporary Pulse GeneratorDTE · Special | 10/31/2003SE |
| K022939 | Oscor Pace 101/101H and Accessories, St.Jude Medical Model 3077 and…DTE · Special | 10/03/2002SE |
| K020896 | Oscor Pace 203/PACE 203H Dual-Chamber Temporary Pacemaker, St. Jude Medical, Model 3085…DTE · Abbreviated | 06/14/2002SE |
Questions and answers
When was Psa Series cleared by the FDA?
Psa Series (K123916) received a 510(k) decision of Unknown on April 9, 2013, 111 days after the submission was received.
What is the product code of K123916?
The FDA product code is DTE – Pulse-Generator, Pacemaker, External, a Class II (moderate risk) device regulated under 21 CFR 870.3600.